Company Description
Founded in Munich, Germany in 1989, Brainlab develops, manufactures and markets software-driven medical technology, enabling access to improved, more efficient, less-invasive patient treatments. Our key to success is our creative, talented and hard-working team, which consists of around 2400 dedicated and inspiring individuals in 25 locations worldwide. To succeed in reaching our targets, we are seeking committed colleagues who can stand behind our core values curious, authentic and useful.
Job Description
We are seeking a dedicated (Senior) Process Engineer within our R&D Office at Brainlab.
You’ll be joining a cross-functional team composed of experienced Process Engineers and Agile Coaches who play a pivotal role in shaping and evolving Brainlab’s product development landscape. This team is responsible for the governance, optimization, and continuous improvement of development processes across the R&D organization. They are aligning with the R&D tool ecosystem, and ensure that our working model and tools are harmonized to support efficient, high-quality product delivery and collaborate with stakeholders across R&D, Quality Management, and Product Management to drive process excellence and foster a culture of agility and innovation.
In the role of (Senior) Process Engineer, you will be responsible for designing, implementing, and continuously improving development processes to ensure compliance with international standards and regulations, while also enabling efficient and innovative development practices across our R&D teams.

Your tasks include:

• Design, implement, and optimize software development processes within R&D in accordance with relevant medical device standards (e.g. ISO 13485, MDR/FDA).
• Analyze effectiveness and efficiency of existing processes and manage process improvement and associated tool projects
• Work cross-functionally with R&D, Quality Management, Quality Assurance and other interfacing departments to maintain a compliant yet efficient development environment
• Ensure audit readiness and support internal and external audits related to R&D processes.
• Align development processes within the Brainlab agile methodology
• Provide process training and coaching to R&D colleagues and facilitate knowledge sharing across the organization.

QUALIFICATIONS

• University degree in engineering or life sciences preferred, but other degrees may be considered
• Professional experience in the design and development of medical devices or in leading process optimization initiatives
• Knowledge of medical device related standards and regulations such as FDA 21 CFR Part 820 and ISO 13485
• Flexibility to adjust processes to align with an evolving working model
• Solution orientation and a structured nature
• Strong communication and documentation skills and ability to work cross-functionally
• Fluent in written and spoken English, German is a plus

• Design, implement, and optimize software development processes within R&D in accordance with relevant medical device standards (e.g. ISO 13485, MDR/FDA).
• Analyze effectiveness and efficiency of existing processes and manage process improvement and associated tool projects
• Work cross-functionally with R&D, Quality Management, Quality Assurance and other interfacing departments to maintain a compliant yet efficient development environment
• Ensure audit readiness and support internal and external audits related to R&D processes.
• Align development processes within the Brainlab agile methodology
• Provide process training and coaching to R&D colleagues and facilitate knowledge sharing across the organization